1135 patients have been enrolled to date from 15 clinical centers. Data are available from 978 patients, representing 584 person-years of follow-up. Of those, 756 (77%) are male and 222 (23%) are female; 419 (43%) are white, 526 (54%) are African-American, and 23 (2%) are Hispanic. Mean age is 40 years. HIV transmission factors included homosexual sex in 497 (51%) and injection drug use in 278 (28%). Median CD4 count (most recent) is 168/mm3 (mean 200/mm3) and median HIV-1 RNA is 44,473 c/mL (mean 184,351 c/mL). 72 (7%) had been diagnosed with a milagnancy prior to enrollment, including 7 (10%) with NHL and 27 (37%) with KS. To date 11 patients (1%) have been diagnosed with 12 malignancies since enrollment: KS (n=3), NHL (1), primary CNS lymphoma (1), skin cancer (3), lung cancer (3), and squamous cell carcinoma of the tongue (1). In addition, 4 women were diagnosed with cervical dysplasia.